US20090306597A1 - Device for unblocking an occluded vessel, and a method for unblocking an occluded vessel - Google Patents

Abstract

A device for unblocking an occlusion (3) in an occluded vessel (2) comprises a catheter (5) having an inflatable balloon (19) located at a distal leading end (8) thereof so that by inflating the balloon (19) the leading end of the catheter (5) may be anchored in the occluded vessel (2) or in a vessel adjacent the occluded vessel (2) with the leading end adjacent the occlusion (3). A guide wire (12) terminating in a pointed distal tip (18) is urgeable through a bore (10) in the catheter (5) for engaging and penetrating through the occlusion (3). A leading portion (17) of the guide wire (12) is externally threaded at (26), and is engageable with an internally threaded portion (25) of the bore (10) adjacent a leading portion (9) of the catheter (5), so that when the catheter (5) is anchored by the balloon (19) with the leading portion (9) of the catheter (5) adjacent and abutting the occlusion (3) with the external threads (26) of the guide wire (12) engaging the internal threads (25) of the catheter (5), rotation of the guide wire (12) urges the distal tip (18) of the guide wire (12) into engagement with the occlusion (3) and to penetrate through the occlusion (3).

Description

• The present invention relates to a device for unblocking an occluded vessel, for example, unblocking an occluded vessel in a human or animal subject, and in particular, though not limited to a device for unblocking an occluded blood vessel, for example, a vessel in the cardiovascular system, and the invention also relates to a method for unblocking a vessel, for example, unblocking a vessel in a human or animal subject, and in particular, though not limited to a method for unblocking an occluded vessel, such as an occluded blood vessel of the type in the cardiovascular system. The invention also relates to a device and a method for remotely forming one of an opening and a bore through one of a medium within a vessel, a medium separating two vessels and a medium forming a vessel.
• Occlusion of blood vessels results from a variety of tissue growth within the vessel. The tissue can become dense and fibrous, and its surface can calcify and harden. The most common minimally invasive treatment for unblocking such vessels is a treatment which is referred to as angioplasty. In an angioplasty treatment a balloon catheter is inserted into the arterial or venal system, typically through one of the femoral arteries or the radial arteries, and is passed through the arterial or venal system to the occluded site. The balloon catheter terminates in a leading portion which carries a balloon, and the leading portion is urged through the occlusion so that the balloon in a deflated state is positioned in the occlusion. Inflating of the balloon dilates the occluded vessel, and a stent, which typically is of tubular wire mesh construction is carried on the exterior of the balloon and is expanded by the inflating of the balloon. The expanded stent remains in place in the occluded region after deflation of the balloon. The stent acts as an implanted scaffold within the vessel for maintaining the occluded region of the vessel dilated.
• However, in order to carry out an angioplasty treatment, the blockage must first be traversed by a wire, typically, a guide wire, which acts as a rail over which the balloon catheter is advanced to the occlusion. Failure to cross the occlusion with the guide wire or to position the balloon catheter with the balloon located within the occlusion requires reverting to traditional surgical invasive techniques in order to unblock the occlusion.
• Typically, in an angioplasty treatment the guide wire which is advanced to the occluded vessel is a relatively stiff wire, and where the occlusion is relatively soft, manually urging the guide wire in its axial direction is sufficient to urge the guide wire through the occlusion. However, in cases where the occlusion becomes calcified and hardened, it is necessary to employ a laser catheter or a radio frequency guide wire in an attempt to pass through the occlusion. Such laser catheters and radio frequency guide wires require relatively expensive external power packs, and also require highly trained personnel for their operation. Additionally, known minimally invasive systems for unblocking an occlusion must be controlled externally of the body by pushing the guide wire through a catheter, which may or may not be a balloon catheter. Thus, control of the tip of the guide wire which is being urged through the occlusion is arbitrary, and there is no guarantee that the tip of the guide wire remains in a substantially central position within the vessel as it is being advanced into engagement with the occlusion. Indeed, it is not uncommon for a guide wire as it is being advanced into engagement with an occlusion, and in particular a relatively hard occlusion, to slide to one side of the occlusion, and thus, lead to dissection of the blood vessel where the tip of the guide wire passes through the wall of the blood vessel, thus separating an inner lining of the wall of the blood vessel from the outer lining. This can create a false lumen within the wall of a blood vessel. In extreme cases the guide wire on slipping to the side of the occlusion, may extend through and exit the wall of the blood vessel, thus perforating the blood vessel, which results in internal bleeding. This problem is further compounded when the occluded vessel is within the cardiovascular system, since the heart moves as it beats, and thus, it is virtually impossible to maintain the tip of the guide wire centrally in the occluded vessel.
• Accordingly, there is a need for a device and a method for minimally invasively unblocking an occluded blood vessel which addresses the problems of known devices and methods.
• The present invention is directed towards providing a device and a method for minimally invasively unblocking an occluded vessel at a remote site, for example, though not limited to an occluded blood vessel in a human or animal subject. The invention also relates to a method and a device for forming one of an opening and a bore through one of a medium within a vessel, a medium separating two vessels and a medium forming a vessel.
• According to the invention there is provided a device for unblocking an occluded vessel at a remote site having an occlusion therein, the device comprising a first elongated member for passing through a lumen to the occluded vessel, the first member terminating in a distal leading portion, the leading portion having a bore extending axially therethrough, an anchoring means located on the first member for anchoring the first member with the leading portion thereof adjacent the occlusion, and a second elongated member terminating in a distal leading portion urgeable through the bore in the leading portion of the first member, the leading portion of the second member terminating in a distal tip for urging through the occlusion for unblocking the occluded vessel, the second member being co-operable with the first member so that the second member is urgeable off the anchored first member into engagement with the occlusion.
• Preferably, a means is provided for converting rotational motion of the second member relative to the first member into linear motion of the second member for advancing the second member into engagement with the occlusion.
• In one embodiment of the invention the bore of the leading portion of the first member is internally threaded, and the leading portion of the second member is externally threaded for co-operating with the threaded bore of the first member for advancing the leading portion of the second member into engagement with the occlusion.
• Preferably, the anchoring means is located adjacent the leading portion of the first member.
• Advantageously, the anchoring means comprises an inflatable balloon located on the first member.
• In one aspect of the invention the leading portion of the first member extends through the inflatable balloon so that the inflatable balloon defines with the leading portion of the first member an annular hollow interior region. Preferably, the inflatable balloon is remotely inflatable. Advantageously, the first member comprises a communicating means for accommodating an inflating medium for remotely inflating the inflatable balloon.
• In another aspect of the invention the bore in the leading portion of the first member extends through the first member to a proximal end thereof for accommodating the second member therethrough.
• Preferably, the first member comprises an elongated catheter, and the second member comprises an elongated wire of relatively high torsional rigidity for transferring angular rotation of the second member adjacent a proximal end thereof into angular rotation adjacent the distal end thereof.
• Advantageously, the anchoring means is adapted for engaging the wall of one of the occluded vessel and a vessel adjacent the occluded vessel for anchoring the leading portion of the first member adjacent the occlusion.
• In one aspect of the invention the device is adapted for unblocking an occluded vessel in a human or animal subject.
• In another aspect of the invention the vessel is a blood vessel.
• Additionally, the invention provides a method for unblocking an occluded vessel at a remote site having an occlusion therein, the method comprising urging a first elongated member through a lumen for locating a distal leading portion of the first member adjacent the occlusion, anchoring the first member by an anchoring means with the leading portion of the first member adjacent the occlusion, locating a distal leading end of an elongated second member in a bore extending through the leading end of the first member to co-operate with the first member, and urging the second member off the anchored first member for urging a distal tip of the leading portion of the second member into engagement with the occlusion.
• Preferably, the distal tip of the second member is urged into engagement with the occlusion by locating the second member relative to the first member, rotating the second member relative to the first member, and converting the rotational motion of the second member into linear motion of the second member relative to the first member.
• In one embodiment of the invention an external thread on the leading portion of the second member is engaged with an internal thread in the bore of the first member for converting the rotational motion of the second member relative to the first member into the linear motion of the second member relative to the first member.
• Advantageously, the second member extends through a bore in the first member which extends from the bore in the leading portion of the first member to a proximal end of the first member.
• In one aspect of the invention the first member is anchored by engaging the anchoring means with a wall of one of the occluded vessel and a vessel adjacent the occluded vessel.
• In another aspect of the invention the anchoring means comprises an inflatable balloon located on the first member, and the inflatable balloon is inflated for anchoring the first member with the leading portion thereof adjacent the occlusion.
• In one aspect of the invention the method is adapted for unblocking an occluded vessel in a human or animal subject.
• In another aspect of the invention the vessel is a blood vessel.
• In another embodiment of the invention the first member with the second member engaged in the occlusion is withdrawn through the lumen, and a balloon stent catheter with a stent located on a balloon of the balloon stent catheter is passed through the lumen over the second member until the balloon with the stent thereon is located in the occlusion, and the balloon of the balloon stent catheter is inflated for dilating the occlusion. Preferably, the balloon of the balloon stent catheter is deflated and the balloon stent catheter and the second member are withdrawn through the lumen leaving the stent in place in the occlusion.
• The invention also provides a device for remotely forming one of an opening and a bore through one of a medium within a vessel, a medium separating two vessels and a medium forming a vessel, the device comprising a first elongated member for passing through a lumen to the medium, the first member terminating in a distal leading portion, the distal leading portion having a bore extending axially therethrough, an anchoring means being located on the first member for anchoring the first member with the leading portion thereof adjacent the medium, a second elongated member terminating in a distal leading portion urgeable through the bore in the leading portion of the first member, the leading portion of the second member terminating in a distal tip for urging through the medium to form the one of the opening and the bore therethrough, the second member being co-operable with the first member so that the second member is urgeable off the anchored first member into engagement with the medium.
• The invention further provides a method for remotely forming one of an opening and a bore through one of a medium within a vessel, a medium separating two vessels and a medium forming a vessel, the method comprising urging a first elongated member through a lumen for locating a distal leading portion of the first member adjacent the medium, anchoring the first member by an anchoring means with the leading portion of the first member adjacent the medium, locating a distal leading end of an elongated second member in a bore extending through the leading end of the first member to co-operate with the first member, urging the second member off the anchored first member for urging a distal tip of the leading portion of the second member into engagement with the membrane.
• The advantages of the invention are many. A particularly important advantage of the invention is that it facilitates axial alignment of the distal tip of the second member with an occlusion in a vessel, and furthermore, facilitates penetrating of the occlusion by the distal tip of the second member substantially along the central axis of the vessel. A further advantage of the invention is that the distal leading portion of the second member is urgeable into and through the occlusion off the leading portion of the first member, since the first member is anchored in or adjacent the occluded vessel. In other words, the anchoring of the first member in or adjacent the occluded vessel provides a solid anchorage against which the second member is urgeable into and through the occlusion.
• Similar advantages are obtained from the invention when the device and the method are used for forming an opening or a bore through a medium which may be located in a vessel, separating a pair of vessels or forming a vessel.
• The invention will be more clearly understood from the following description of some preferred embodiments thereof, which are given by way of example only, with reference to the accompanying drawings, in which:
• FIG. 1 is a perspective view of a device according to the invention for unblocking an occluded vessel,
• FIG. 2 is a cross-sectional side elevational view of the device ofFIG. 1,
• FIG. 3 is a cross-sectional side elevational view of the device ofFIG. 1 showing a portion of the device in a different position,
• FIG. 4 is an enlarged cross-sectional side elevational view of a portion of the device ofFIG. 1,
• FIG. 5 is an enlarged perspective cross-sectional view of the portion ofFIG. 4 of the device ofFIG. 1,
• FIG. 6 is an enlarged perspective view of the portion ofFIG. 4 of the device ofFIG. 1,
• FIG. 7 is a cutaway perspective view of the device ofFIG. 1 in use,
• FIG. 8 is a perspective cross-sectional view of the device ofFIG. 1 also in use, and
• FIG. 9 is an enlarged side elevational view of a portion of a device according to another embodiment of the invention for unblocking an occluded vessel.
• Referring to the drawings, and initially toFIGS. 1 to 8 thereof, there is illustrated a device according to the invention, indicated generally by thereference numeral1, for unblocking anoccluded blood vessel2 of the cardiovascular system (not shown) which has been occluded by anocclusion3 formed by toughened hardened tissue which has become calcified and hardened into a hard plaque. Thedevice1 comprises a first elongated member, namely, anelongated catheter5 extending from aproximal end7 to adistal end8, which terminates in a leadingportion9 for locating in thevessel2 adjacent theocclusion3. A bore10 extends longitudinally through thecatheter5 and through the leadingportion9 for accommodating a second elongated member, namely, aguide wire12 which also extends from aproximal end14 to adistal end15. Thedistal end15 of theguide wire12 terminates in a leadingportion17 which in turn terminates in a pointeddistal tip18 for penetrating through theocclusion3 as will be described below. Theproximal end14 of theguide wire12 terminates in acylindrical handle16, seeFIG. 2, for facilitating rotating of theguide wire12 in thebore10 of thecatheter5 as will be described below.
• An anchoring means comprising aninflatable balloon19 is located adjacent thedistal end8 of thecatheter5 for anchoring thecatheter5 in thevessel2. Thecatheter5 extends through theballoon19 so that theballoon19 defines with thecatheter5 an annular hollowinterior region20. In this embodiment of the invention thecatheter5 is of double wall construction, having aninner wall21 and anouter wall22, which define therebetween anannular passageway23 extending from theballoon19 to theproximal end7 for accommodating a suitable inflating medium, for example, an X-ray opaque dye solution therethrough to and from the hollowinterior region20 of theballoon19 for inflating and deflating theballoon19. Thus, when thecatheter5 is located in thevessel2 with the leadingportion9 adjacent theocclusion3, theballoon19 is inflated for anchoring thecatheter5 with the leadingportion9 adjacent theocclusion3 as illustrated inFIGS. 6 and 7. Acoupling unit24 at theproximal end7 of thecatheter5 is provided for coupling theannular passageway23 to a source (not shown) of the inflating medium for inflating theballoon19.
• Theguide wire12 and thecatheter5 co-operate with each other so that when thecatheter5 is anchored in thevessel2 by theinflated balloon19, the leadingportion17 of theguide wire12 is urgeable off the leadingportion9 of thecatheter5 for urging thedistal tip18 of theguide wire12 into engagement with theocclusion3. In this embodiment of the invention the co-operating action between theguide wire12 and thecatheter5 is achieved by providing aninternal screw thread25 in thebore10 of the leadingportion9 of thecatheter5 which co-operates with a correspondingexternal screw thread26 on the leadingportion17 of theguide wire12. The co-operating action between the internal andexternal screw threads25 and26 results in rotation of theguide wire12 in the appropriate angular direction being converted into linear motion of theguide wire12 relative to thecatheter5 for urging thedistal tip18 of theguide wire12 outwardly of thebore10 and into engagement with theocclusion3 for penetrating therethrough.
• Theguide wire12 has a relatively high degree of torsional rigidity so that rotation of theproximal end14 of theguide wire12 is transferred into rotation of thedistal end15 of theguide wire12.
• In use, initially a standard soft tipped guide wire (not shown) is entered into the arterial network of the body through one of the femoral arteries and is urged through the arterial network into the arterial cardiovascular system until the leading distal portion of the standard guide wire is located in theoccluded vessel2 adjacent theocclusion3. On the standard guide wire (not shown) with the distal tip thereof being located adjacent theocclusion3, thecatheter5 of thedevice1 is then advanced over the standard guide wire until its leadingportion9 is located in thevessel2 adjacent and substantially abutting theocclusion3. Theballoon19 is then inflated by a suitable inflating medium, for example, an X-ray opaque dye until theballoon19 engages the inner periphery of the wall of the vessel4 and the leadingportion9 of thecatheter5 is securely and centrally axially anchored in the vessel4. The standard guide wire is withdrawn through thebore10 of thecatheter5 and removed.
• Theguide wire12 is then advanced through thebore10 of thecatheter5 until the leadingportion17 of theguide wire12 is located in thebore10 adjacent the leadingportion9 of thecatheter5. At this stage thehandle16 of theguide wire12 is gripped by hand and rotated for rotating theguide wire12 in the appropriate direction about its longitudinal axis for engaging theexternal thread26 of the leadingportion17 of theguide wire12 with theinternal thread25 in the leadingportion9 of thecatheter5. Further rotation of theguide wire12 advances the leadingportion17 of theguide wire12 through the threaded portion of thebore10, and in turn advances thedistal tip18 of theguide wire12 into engagement with theocclusion3. Theguide wire12 is rotated until thedistal tip18 has penetrated completely through theocclusion3.
• When the leadingportion17 of theguide wire12 has been advanced completely through theocclusion3, two options are available to stent the occlusion. Either theguide wire12 may be left in place for guiding a balloon stent catheter (not shown) of the type which will be well known to those skilled in the art to theocclusion3, or theguide wire12 may be replaced by a standard guide wire (also not shown) for guiding a balloon stent catheter (not shown) to theocclusion3. Should it be desired to use theguide wire12 for guiding a balloon stent catheter (not shown) to the occlusion, theballoon19 of thecatheter5 is deflated and thecatheter5 is removed. The balloon stent catheter (not shown) is then advanced over theguide wire12, and the balloon with the stent located thereon is located in theocclusion3. The balloon of the balloon stent catheter is then inflated, thereby urging the stent radially outwardly against theocclusion3, and in turn dilating theocclusion3. The balloon of the balloon stent catheter is then deflated, leaving the stent in place, which thereafter retains the occlusion in the dilated state with thevessel2 unblocked and open. The balloon catheter with the deflated balloon and theguide wire12 are removed.
• Alternatively, should it be desired to use a standard guide wire (not shown) to guide the balloon stent catheter (not shown) to theocclusion3, with theballoon19 of thecatheter5 still inflated and anchoring the leadingportion9 of thecatheter5 in thevessel2, theguide wire12 is then withdrawn through theocclusion3 until theexternal thread26 on the leadingportion17 of theguide wire12 engages theinternal thread25 of thebore10 adjacent the leadingportion9 of thecatheter5. Thehandle16 of thecatheter12 is then rotated in the appropriate direction for in turn rotating the leadingportion17 of theguide wire12 relative to the leadingportion9 of thecatheter5 for urging the leadingportion17 of theguide wire12 into and through the threaded bore10 of the leadingportion9 of thecatheter5 until theexternal thread26 on the leadingportion17 of theguide wire12 has cleared theinternal thread26 on the leadingportion9. Thereafter theguide wire12 is withdrawn from thecatheter5 by pulling theguide wire12 through thebore10 of thecatheter5.
• On removal of theguide wire12 from thecatheter5, a standard guide wire (not shown) is advanced through thebore10 of thecatheter5 until the leading distal end of the standard guide wire passes across and through theocclusion3. With thestandard guide wire5 so located in theocclusion3, theballoon19 of thecatheter5 is deflated and thecatheter5 is removed. The balloon stent catheter (not shown) is then advanced over the standard guide wire until the balloon with the stent located thereon is located in theocclusion3. Thereafter the balloon of the balloon stent catheter is inflated as already described to urge the stent radially outwardly against theocclusion3. With the stent in place in theocclusion3, the balloon of the balloon stent catheter is deflated and the standard guide wire and the balloon catheter are then removed.
• By replacing theguide wire12 with a standard guide wire, a variety of tools may be advanced over the standard guide wire, such as stents, balloon catheters, laser catheters, arthrectomy catheters and other such catheters and devices.
• A particularly important advantage of the invention is achieved by virtue of the fact that the leadingportion17 of theguide wire12 is in screw thread engagement with the leadingportion9 of thecatheter5. Rotation of theguide wire12 relative to thecatheter5 advances the leadingportion17 of theguide wire12 through theocclusion3. This, thus, gives a significant mechanical advantage over and above known methods where the leading portion of the guide wire is merely urged slidingly linearly through the bore of acatheter5 for engaging and penetrating through an occlusion. In fact, the mechanical advantage achieved by the catheter and guide wire combination of thedevice1 according to the invention is:
• 
  π.D/p
• where
• • D is the outer diameter of thehandle16 of theguide wire12, and
  • p is the pitch of the internal andexternal threads25 and26.
• Accordingly, the larger the diameter of thehandle16, the greater will be the mechanical advantage, and similarly, by reducing the pitch of the threads, the mechanical advantage is likewise increased. Accordingly, by providing theguide wire12 with the appropriate degree of torsional rigidity, the guide wire can be readily rotated by thehandle16 at theproximal end14 thereof for, in turn, advancing the leadingportion17 of theguide wire12 through thebore10 of the leadingportion9 of thecatheter5 for penetrating theocclusion3.
• Another advantage of the device according to the invention is that it provides relatively fine pitch control to a user.
• Referring now toFIG. 9, there is illustrated a portion of a device also according to the invention indicated generally by thereference numeral30 also for unblocking an occluded vessel. Thedevice30 is substantially similar to thedevice1 which has been described with reference toFIGS. 1 to 8, and similar components are identified by the same reference numerals. The only difference between thedevice30 and thedevice1 is in the anchoring means. In this embodiment of the invention the anchoring means comprises aballoon19 formed by a plurality of interconnectedannular segments31. Otherwise, thedevice30 is similar to thedevice1 and its use is likewise similar to that of thedevice1.
• The advantage of thedevice30 is achieved by virtue of the fact that theballoon19 is formed by theannular segments31. The provision of theballoon19 in the form ofannular segments31 permits thecatheter5 adjacent its leading portion, when theannular segments31 are inflated, to follow the curvature of anoccluded vessel2 if thevessel2 is of curved configuration. By permitting the portion of thecatheter5 adjacent the leadingportion9 thereof to follow the curvature of theoccluded vessel2 permits the leadingportion9 of thecatheter5 to be centrally aligned with the occlusion, and in turn, the pointeddistal tip18 of the leadingportion17 of theguide wire12 to be centred on the occlusion. Otherwise, if the occluded vessel were of curved configuration and the portion of thecatheter5 adjacent the leadingportion9 thereof did not follow the curvature of the vessel, the pointeddistal tip18 of the leadingportion17 of theguide wire12 would not necessarily be centred on the occlusion when the leadingportion9 of thecatheter5 would be anchored in the vessel, and further advancing of the leadingportion17 of theguide wire12 out of thebore10 of the leadingportion9 could direct thepointed tip18 of the leadingportion17 of theguide wire12 through the wall of the vessel.
• While the devices have been described for use for unblocking a vessel of an artery of the cardiovascular system, it will be readily apparent to those skilled in the art that the devices may be used for unblocking a vessel of any vascular system, whether arterial or venal. Needless to say, it will be appreciated that the devices may also be used for unblocking an occluded vessel in any other part of the body, for example, in the kidney, urinary tract or any other organ or vessel. Additionally, it is envisaged that the devices according to the invention and the method according to the invention may be used for unblocking an occlusion in any vessel, whether a biological vessel or a non-biological vessel, whether the vessel is in a human or animal body, or entirely unconnected with a human or animal body.
• It is also envisaged that the devices and the methods according to the invention may be used for unblocking an occlusion in the gastrointestinal tract.
• While the devices according to the invention have been described for unblocking a vessel, the devices according to the invention has many other uses, for example, the devices according to the invention may be used for remotely forming an opening or a bore in or through a medium or a membrane in a vessel, for example, for forming an opening in a membrane dividing a vessel or a membrane separating two vessels. However, in which case an appropriate anchoring means would be provided for anchoring the first member with the leading portion thereof adjacent the membrane at the location thereof through which the opening is to be formed. For example, if the devices were used to form an opening in a membrane or a wall of the heart which separates the heart into two or more vessels, the anchoring means would be appropriately provided for anchoring the first member with the leading portion thereof adjacent the membrane or wall of the heart at the location at which the opening is to be formed therethrough. Such an anchoring means may be provided by an appropriately sized and shaped balloon for engaging the walls of the vessel when inflated to facilitate anchoring of the first member with the leading portion thereof adjacent the membrane or wall. Further, the devices according to the invention may be used for drilling or forming a bore into tissue, such as muscle tissue of the heart for providing a blood supply to the muscle tissue.
• Indeed, a further advantage of the devices according to the invention is their adaptability, and in particular, their adaptability for forming an opening or a bore in or through a medium, membrane or the like. Indeed, surgeons commonly wish to form a hole in the wall of the heart, for example, between chambers of the heart, and it is also not uncommon for surgeons to wish to create a communication between an artery or vein or other organs. These types of procedures are commonly carried out using a needle with a curved tip exiting a protecting catheter which is simply pushed through the catheter. By using the devices according to the invention for forming such a hole or creating such a communication, a safer and more controlled approach can be achieved, and such a safer, more controlled approach is readily achievable when the devices are provided with an externally threaded leading portion on the guide wire and an internally threaded bore in the leading portion of the catheter, since in which case the amount and rate of advance of the leading portion of the guide wire relative to the leading portion of the catheter can be finely controlled by controlling the angular rotation of the guide wire and the speed of rotation, as well as by appropriately selecting the thread pitch on the leading portion of the guide wire and in the bore of the leading portion of the catheter.
• While the anchoring means has been described as comprising an annular balloon located adjacent the leading portion of the catheter, any other suitable anchoring means may be provided. Indeed, it will be readily apparent to those skilled in the art that a balloon of other shape and construction, which may or may not extend completely around the catheter, may be provided, and such a balloon typically would be shaped so that when inflated the balloon would define at least a portion of the interior of the vessel within which the catheter is to be anchored. Needless to say, the anchoring means may be provided at any other suitable location of the catheter besides adjacent the leading portion, and in certain cases, it is envisaged that the anchoring means may be provided remote of the leading portion.
• While the co-operating action between the catheter and the guide wire has been described as being achieved by threading the leading portions of the guide wire and the catheter, other suitable co-operating means may be provided, which facilitates the leading portion of the guide wire to act against the leading portion of the catheter so that the guide wire can be urged off the catheter for penetrating the occlusion. It will also be appreciated that while the first member has been described as being provided by a catheter, any other suitable elongated member which terminates with a leading portion through which a bore extends may be used.
• While the leadingportion17 of theguide wire12 has been described as terminating in apointed tip18, the leadingportion17 may terminate in a tip of any other configuration, for example, the tip may be radiused, spade-edged, or the tip may be configured as a cutter, for example, with a serrated edge. Additionally, it is envisaged that the leading portion of the guide wire may terminate in a drill bit, or other suitable bit for boring or forming an opening or a bore in and through a medium, membrane, tissue, muscle tissue, occlusion or the like. Indeed, in certain cases, it is envisaged that the leading portion of the guide wire may terminate in a fluted drill bit.
• It is envisaged that the internal threaded portion of the leading portion of the catheter may be provided as a separate element, which would be releasably secured to the leading portion of the catheter, and typically, would be releasably secured to the leading portion of the catheter adjacent the leading portion of the catheter extending from the distal portion of the inflatable balloon by, for example, a separate screw threaded arrangement, by a bayonet securing arrangement, or by any other suitable securing arrangement. Indeed, it is envisaged that where the threaded leading portion of the bore of the leading portion of the catheter is provided as a separate element, the said separate element would be internally threaded, and could form an internal sleeve extending into thebore10 adjacent the leading end of the catheter.

Claims (20)

1. A device for unblocking an occluded vessel at a remote site having an occlusion therein, the device comprising a first elongated member for passing through a lumen to the occluded vessel, the first member terminating in a distal leading portion, the leading portion having a bore extending axially therethrough, an anchoring means located on the first member for anchoring the first member with the leading portion thereof adjacent the occlusion, and a second elongated member terminating in a distal leading portion urgeable through the bore in the leading portion of the first member, the leading portion of the second member terminating in a distal tip for urging through the occlusion for unblocking the occluded vessel, the second member being co-operable with the first member so that the second member is urgeable off the anchored first member into engagement with the occlusion.

2. A device as claimed inclaim 1 in which a means is provided for converting rotational motion of the second member relative to the first member into linear motion of the second member for advancing the second member into engagement with the occlusion.

3. A device as claimed inclaim 1 in which the bore of the leading portion of the first member is internally threaded, and the leading portion of the second member is externally threaded for co-operating with the threaded bore of the first member for advancing the leading portion of the second member into engagement with the occlusion.

4. A device as claimed inclaim 1 in which the anchoring means is located adjacent the leading portion of the first member.

5. A device as claimed inclaim 1 in which the anchoring means comprises an inflatable balloon located on the first member, and preferably, the leading portion of the first member extends through the inflatable balloon so that the inflatable balloon defines with the leading portion of the first member an annular hollow interior region, and advantageously, the inflatable balloon is remotely inflatable, and preferably, the first member comprises a communicating means for accommodating an inflating medium for remotely inflating the inflatable balloon.

6. A device as claimed inclaim 1 in which the bore in the leading portion of the first member extends through the first member to a proximal end thereof for accommodating the second member therethrough.

7. A device as claimed inclaim 1 in which the first member comprises an elongated catheter, and the second member comprises an elongated wire of relatively high torsional rigidity for transferring angular rotation of the second member adjacent a proximal end thereof into angular rotation adjacent the distal end thereof.

8. A device as claimed inclaim 1 in which the anchoring means is adapted for engaging the wall of one of the occluded vessel and a vessel adjacent the occluded vessel for anchoring the leading portion of the first member adjacent the occlusion.

9. A device as claimed inclaim 1 in which the device is adapted for unblocking an occluded vessel in a human or animal subject, for example, a blood vessel.

10. A method for unblocking an occluded vessel at a remote site having an occlusion therein, the method comprising urging a first elongated member through a lumen for locating a distal leading portion of the first member adjacent the occlusion, anchoring the first member by an anchoring means with the leading portion of the first member adjacent the occlusion, locating a distal leading end of an elongated second member in a bore extending through the leading end of the first member to co-operate with the first member, and urging the second member off the anchored first member for urging a distal tip of the leading portion of the second member into engagement with the occlusion.

11. A method as claimed inclaim 10 in which the distal tip of the second member is urged into engagement with the occlusion by locating the second member relative to the first member, rotating the second member relative to the first member, and converting the rotational motion of the second member into linear motion of the second member relative to the first member.

12. A method as claimed inclaim 11 in which an external thread on the leading portion of the second member is engaged with an internal thread in the bore of the first member for converting the rotational motion of the second member relative to the first member into the linear motion of the second member relative to the first member.

13. A method as claimed inclaim 10 in which the second member extends through a bore in the first member which extends from the bore in the leading portion of the first member to a proximal end of the first member.

14. A method as claimed inclaim 10 in which the first member is anchored by engaging the anchoring means with a wall of one of the occluded vessel and a vessel adjacent the occluded vessel.

15. A method as claimed inclaim 10 in which the anchoring means comprises an inflatable balloon located on the first member, and the inflatable balloon is inflated for anchoring the first member with the leading portion thereof adjacent the occlusion, and preferably, the inflatable balloon is remotely inflatable.

16. A method as claimed inclaim 10 in which the first member is provided as a catheter, and the second member is provided as an elongated wire of relatively high torsional rigidity for transferring angular rotation of the second member adjacent a proximal end thereof into angular rotation adjacent the distal end thereof.

17. A method as claimed inclaim 10 in which the method is adapted for unblocking an occluded vessel in a human or animal subject, for example, a blood vessel.

18. A method as claimed inclaim 10 in which the first member with the second member engaged in the occlusion is withdrawn through the lumen, and a balloon stent catheter with a stent located on a balloon of the balloon stent catheter is passed through the lumen over the second member until the balloon with the stent thereon is located in the occlusion, and the balloon of the balloon stent catheter is inflated for dilating the occlusion, and preferably, the balloon of the balloon stent catheter is deflated and the balloon stent catheter and the second member are withdrawn through the lumen leaving the stent in place in the occlusion.

19. A device for remotely forming one of an opening and a bore through one of a medium within a vessel, a medium separating two vessels and a medium forming a vessel, the device comprising a first elongated member for passing through a lumen to the medium, the first member terminating in a distal leading portion, the distal leading portion having a bore extending axially therethrough, an anchoring means being located on the first member for anchoring the first member with the leading portion thereof adjacent the medium, a second elongated member terminating in a distal leading portion urgeable through the bore in the leading portion of the first member, the leading portion of the second member terminating in a distal tip for urging through the medium to form the one of the opening and the bore therethrough, the second member being co-operable with the first member so that the second member is urgeable off the anchored first member into engagement with the medium.

20. A method for remotely forming one of an opening and a bore through one of a medium within a vessel, a medium separating two vessels and a medium forming a vessel, the method comprising urging a first elongated member through a lumen for locating a distal leading portion of the first member adjacent the medium, anchoring the first member by an anchoring means with the leading portion of the first member adjacent the medium, locating a distal leading end of an elongated second member in a bore extending through the leading end of the first member to co-operate with the first member, urging the second member off the anchored first member for urging a distal tip of the leading portion of the second member into engagement with the membrane.

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